🇳🇬 Nigeria medical device regulatory data

NAFDAC advertisement approvals are valid for one (1) year, extendable to two (2) years upon payment of double the relevant fee if the concept is retained; advertisement fees are charged per single product and per variant (per medium/concept/version/language).

Registration of a device does not automatically confer an Advertisement Permit; a separate application and NAFDAC approval is required before a product may be advertised, per the NAFDAC Guidelines on Advertisement.

A successful device registration is issued a Certificate of Registration with a validity period of five (5) years; the certificate should be renewed upon expiration, and product licenses are renewed every five years.

A renewal application can be initiated six (6) months before the current registration certificate expires; each device, IVD and related product requires its own renewal application.

Any product with an expired registration license is considered an unregistered product; a late renewal of registration license/listing certificate carries an additional charge.

NAFDAC (National Agency for Food and Drug Administration and Control) controls medical devices, IVDs and related products: no device may be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless registered with NAFDAC under the NAFDAC Act CAP N1 (LFN) 2004.

Where the category of change selected by the applicant is inappropriate, NAFDAC will advise the market authorization holder to amend the category as deemed appropriate.

Changes to registered devices fall into three categories: (1) Critical changes affect safety, quality and performance and require NEW registration; (2) Major changes require NAFDAC evaluation and approval prior to implementation and before placing on the Nigerian market; (3) Minor changes may be implemented immediately but still require prior NAFDAC approval before implementation.

IVD classification: Class A low individual and low public health risk; Class B low-moderate individual and/or low public health risk; Class C high individual and/or moderate public health risk; Class D high individual and high public health risk (s.2.2).

Classification follows GHTF/SG1/N077:2012 Principles of Medical Devices Classification as acknowledged in the conformity assessment guideline (non-IVD), with class-based conformity assessment tables for Classes A-D.

Axis

Risk classes A through D for devices and IVDs (NAFDAC registration guidelines 2025).

Classes

• Id

  a

  Label

  Class A

  Normalized Risk Level

  low

• Id

  b

  Label

  Class B

  Normalized Risk Level

  medium

• Id

  c

  Label

  Class C

  Normalized Risk Level

  high

• Id

  d

  Label

  Class D

  Normalized Risk Level

  highest

Regulator

NAFDAC

Notes

• Section 2.1: Class A low risk, B low-to-moderate, C moderate-to-high, D high risk, or any other class the Agency deems fit; where a device belongs to more than one class the higher-risk class applies.
• Section 2.2 IVDs: Class A low individual/low public health risk; B low-moderate individual and/or low public; C high individual and/or moderate public; D high individual and high public.
• Non-IVD classification follows GHTF/SG1/N077:2012 Principles of Medical Devices Classification as acknowledged in the NAFDAC conformity assessment guideline for non-IVD devices (class-based conformity assessment tables for Classes A-D).

NAFDAC's conformity assessment framework incorporates GHTF SG5 clinical evidence documents: N1R8:2007 Clinical Evidence Key Definitions, N2R8:2007 Clinical Evaluation, N3:2010 Clinical Investigations, and N4:2010 Post Market Clinical Follow-Up Studies; class-based conformity assessment may require more clinical evidence for higher-risk devices.

Nigeria applies the IMDRF/GHTF definitions: the guidelines are built on GHTF/SG1/N71:2012 'Definition of the Terms Medical Device and In Vitro Diagnostic Medical Device'; separate classification and conformity assessment documents exist for IVD vs non-IVD devices.

SaMD is regulated as a medical device: 'software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device'; SaMD includes IVD medical devices and mobile apps meeting the definition; software driving a hardware device is not SaMD.

A comprehensive Certificate of Analysis on the QC laboratory's letterhead must accompany the application, stating brand name, batch number, manufacturing and expiry dates, and analyst name, designation and signature.

For imported devices, a Certificate of Manufacture and Free Sale issued by the relevant health/regulatory body in the country of manufacture must be authenticated by the Nigerian Embassy or High Commission in the country of origin; Commonwealth or ECOWAS countries may authenticate in countries without a Nigerian Embassy.

A product dossier in the NAFDAC IMDRF Table of Contents format is required: IVD ToC applicable to IVD Classes C and D, and nIVD ToC applicable to non-IVD Classes C and D; all technical documents must be submitted in electronic format and originals presented upon request.

For imported devices, a Notarized Declaration (Appendix 1 of the registration guideline) must be completed typed, signed by the declarant, and notarized by a Notary Public in Nigeria.

For Class C and D devices (incl. IVDs), the applicant must notify the Directorate of the submission by email at md.vbmrr@nafdac.gov.ng stating the application number, to progress the dossier to full review.

The dossier must include evidence of the manufacturer's quality management system certification and a written Declaration of Conformity stating compliance with the Essential Principles of Safety and Performance, classification per the rules, and conformity assessment completion; a GMDN code/term (where available) and a certificate of compliance with recognized standards (where available) are included.

Registration documents must include evidence of business incorporation by the Nigerian Corporate Affairs Commission (CAC), so the applicant/local agent is a Nigerian-incorporated company; brand name must additionally be registered with the Trademark Registry (Ministry of Industry, Trade and Investment).

An applicant filing on behalf of an overseas manufacturer must file a Power of Attorney issued by the manufacturer, signed by a senior officer, stating brand-name ownership, notarized by a Notary Public in the country of manufacture, and valid for at least five years.

For device post-market surveillance: the manufacturer monitors performance, reports events and initiates FSCA; the MAH liaises with NAFDAC and submits reports; importers/distributors communicate Field Safety Notices and maintain distribution records; healthcare providers detect and report incidents.

An original Clean Report of Inspection and Analysis (CRIA) is required for products coming from China and India, where applicable, as part of the port clearance package.

Imported medical devices are cleared at ports via https://ports.nafdac.gov.ng (PIDCARMS) with uploaded documents including SGD form, commercial invoice, PAAR, Form M, Bill of Lading/Airway Bill, packing list, Form C-30, letter of undertaking, evidence of valid NAFDAC product registration, and manufacturer Certificate of Analysis; the consignment undergoes joint inspection and two endorsements before e-release.

NAFDAC will not entertain new applications for registration of imported regulated products on the Federal Government Import Prohibition List and the NAFDAC Ceiling List.

The Instructions for Use must minimally include: description of intended use (what is measured/detected, function, disorder/condition of interest, automation, reported result type, specimen type and source, target population); test principles; description of reagents/calibrators/controls; materials provided and required; in-use stability; specimen collection/shipping/handling conditions; traceability of calibrator and trueness-control values; assay procedure and interpretation; analytical performance characteristics; clinical performance characteristics where relevant; reference intervals; interfering substances/limitations; and references where relevant.

All imported and locally manufactured devices must bear minimum label information: device name; manufacturer name and address; device identifier; group/family where applicable; batch or lot number; contents description; the word 'sterile' if sold sterile; 'for single use only' where applicable; manufacturing and expiry date (month/year) where applicable; directions for use unless not required; and special storage conditions. If the package is too small, the directions for use must accompany the device but need not appear on the outside of the package.

NAFDAC published the draft 'NAFDAC Medical Devices, including In-vitro Diagnostics and Related Products Regulations, 2026' for comment on 6th February 2026; the comment period is closed. It is not yet in force.

The device registration guidelines must be read in conjunction with IMDRF/GHTF documents, including GHTF/SG1/N71:2012 (definitions), IMDRF IVD MA ToC N13 and nIVD MA ToC N9 (2019 dossier formats), and GHTF/SG1/N70:2011 (label and IFU).

NAFDAC's current official guidance surface is the Guidelines index (nafdac.gov.ng/regulatory-resources/guidelines), which catalogues device registration, renewal, variations, conformity assessment, GMP, PMS, PMPF and adverse-event guidelines; the application surface is the NAPAMS portal (registration.nafdac.gov.ng), not iRIMS.

NAFDAC Act CAP N1 (LFN) 2004 is the primary legal basis; device registration obligations are stated as 'in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislation, and the accompanying Guidelines'.

A post-market surveillance plan must be developed in accordance with the NAFDAC Guidelines for Detecting and Reporting Adverse Reactions for Pharmaceutical Products and Medical Devices including IVDs.

NAFDAC publishes a dedicated 'Guidelines for Post-Market Performance Follow-up (PMPF) for Medical Devices including IVDs' (guidance document, PV category) in its official guidelines catalog.

Manufacturers must operate a trending system monitoring frequency/severity of incidents, conducted periodically (e.g. monthly), and summarize all feedback into periodic reports to the Director PMS as required by the Medical Device Regulation.

Device registration applications are submitted and processed on the NAPAMS portal at https://registration.nafdac.gov.ng; to initiate an IVD/non-IVD dossier submission the applicant emails md.vbmrr@nafdac.gov.ng to receive a unique upload link.

The online application form for product registration renewal is purchased on the NAFDAC registration portal (http://registration.nafdac.gov.ng) and completed for each device, IVD and related product requiring renewal.

For Class A devices the manufacturer may establish either a full QMS or a QMS without design and development controls; regulatory oversight increases from Class A to D as evidence and conformity assessment requirements become more demanding.

Premises for the manufacture of devices, IVDs and related products are inspected in accordance with the applicable regulations, the NAFDAC GMP guidelines, the current ISO 13485:2016 and other applicable international standards; GMP inspection is risk-based, considering product/process risk, compliance history, device-usage risk and recall actions.

An FSCA is triggered by incidents with distributed devices posing an unacceptable increase in risk (malfunction/deterioration, inadequate information, undesirable side effects); FSCA actions include device recall (return to manufacturer/representative), modification, exchange, destruction, or use advice; an FSCA is communicated through a Field Safety Notice (FSN), and manufacturers report any FSCA to the Agency as required by the Medical Devices Regulations.

Manufacturers (or MAHs) must send NAFDAC an investigation report: Serious Public Health Threat - immediate, not later than 48 hours; Death or Serious Deterioration in Health - as soon as possible, not later than 10 calendar days; Potential Death or Serious Deterioration - not later than 30 calendar days.

A Dossier Screening Clearance is a prerequisite for submitting registration applications for moderate and high-risk (Class B, C, D) IVD and non-IVD medical devices on NAPAMS.

After satisfactory documentation review, GMP inspection of the production facility and laboratory analysis (where applicable), products are presented to the Food and Drug Registration Committee (FDRC) for approval.

For imported devices, after document screening NAFDAC issues a Permit to Import electronically via the NAPAMS portal, authorizing importation of registration samples for laboratory testing/evaluation.

Device registration applications are submitted and processed on the NAFDAC Automated Products Administration and Monitoring System (NAPAMS) portal at https://registration.nafdac.gov.ng (previously described as the iRIMS portal in the baseline).

A separate application is required for each medical device, IVD, related product, device group, device family or device system; a separate application form is required for each product, product group, product family or system.

The device registration processing timeline is suspended when NAFDAC issues a Compliance Directive ('the clock stops once compliances are issued'); the timeline runs to a maximum of 240 work days from acceptance of submission to issuance of the registration number.

No donated medical product (drugs, devices incl. IVDs) may be imported into Nigeria unless it has undergone due processing with NAFDAC under the donated-products guideline and a Permit to Import the specific donated items is issued; the recipient organization must demonstrate capacity (e.g. cold chain), liaise with the NAFDAC State Coordinator, and invite NAFDAC officers to witness use.

NAFDAC's EUA is a special procedure granting time-limited listing authorization for unlicensed vaccines, therapeutics and medical devices (incl. IVDs) during a declared public health emergency, based on an essential set of available quality, safety and performance data; EUA is not equivalent to registration, and manufacturers are expected to complete development and submit for licensure.

NAFDAC issues a Permit for Service Drugs (including orphan drugs)/Medical Devices per product for special-need devices that are not registered or not available in Nigeria, requested for use by expatriates or patients advised to use such brands.

Clients must comply with a NAFDAC Compliance Directive (CD) within 7 working days of issuance; failure to comply with any CD may result in cancellation of the application.

Delays caused by the client are not counted within the registration processing timelines.

Failure to respond promptly to NAFDAC queries or enquiries on an application (within ninety (90) days) will automatically lead to closure of the application.

The Declaration of Conformity must contain a Global Medical Devices (including IVDs) code and term for the device(s), where available.

Importers and distributors must communicate Field Safety Notices and maintain distribution records as their post-market responsibility, supporting device traceability through the supply chain.

Dealers (distributors/suppliers/agents) of medical devices must follow up an initial reportable adverse event with a final report within 30 days of the initial report; if more than one dealer of a brand is involved, each must submit their own report.

Manufacturers must report device adverse events to NAFDAC: Death - 48 hours of becoming aware; Serious Injury within Nigeria - 48 hours; Serious Injury outside Nigeria - 15 calendar days; Public Health Concern - 10 calendar days; possible death or serious injury if the event recurs - 30 calendar days; Non-Serious Injury within Nigeria - 90 calendar days; non-serious injury outside Nigeria - contained in the PSUR. Non-serious injuries are also reportable.

Adverse event reports must be submitted using the Medical Device Adverse Event Reporting Form for Manufacturers (Appendix 1) or for End Users (Appendix 2) through pharmacovigilance@nafdac.gov.ng or at the nearest NAFDAC office; email size under 2MB.

Manufacturers must train distributors, suppliers and agents on NAFDAC device reporting requirements (keeping training plans and records as evidence), and distributors/suppliers collect and collate adverse event reports on the manufacturer's behalf under a signed vigilance agreement.

Device user facilities report adverse events using the end-user form: Death - 48 hours; Serious Injury - 48 hours; Public Health Concern - 10 calendar days; possible death or serious injury if recurrence - 30 calendar days; Non-Serious - 90 calendar days. Reports to manufacturers must also be notified to NAFDAC with documentary evidence.